Interesting Discussion Using a Wiki to implement a Quality Management System (QMS)

Pancho

wikineer
Super Moderator
#1
I had an epiphany recently.

My company documented and implemented an ISO 9001:2008 compliant Quality Management System on a wiki.

The epiphany part is the realization of how incredibly, amazingly, unbelievably useful the wiki is to complete this process. In fact, it is so useful that I now feel this urge to evangelize. Hence my contribution here.

If one of you finds this half as useful as we did at Geometrica, my work is done. :)

Cheers!
Pancho
 
Last edited by a moderator:
Elsmar Forum Sponsor
C

Craig H.

#2
Re: Using a wiki to implement a QMS

Pancho,

This is very well written, and quite an interesting concept. Thank you VERY much for sharing.
 

Le Chiffre

Quite Involved in Discussions
#3
Re: Using a wiki to implement a QMS

I'm glad to see someone else using a wiki for this task. We started using one for our QMS 3 years ago and it's been through ISO 9001 and ISO 13485 audits. We've reached almost 3,000 pages but the wiki is now used for every aspect of the business.

You have to be careful to identify "controlled" records and to show the approval state of some articles, alerting the reader if the article has changed since being reviewed - it may be in a state of flux during an edit when someone else takes instruction from it.
 

Stijloor

Leader
Super Moderator
#4
Re: Using a wiki to implement a QMS

I'm glad to see someone else using a wiki for this task. We started using one for our QMS 3 years ago and it's been through ISO 9001 and ISO 13485 audits. We've reached almost 3,000 pages but the wiki is now used for every aspect of the business.

You have to be careful to identify "controlled" records and to show the approval state of some articles, alerting the reader if the article has changed since being reviewed - it may be in a state of flux during an edit when someone else takes instruction from it.
Where can a "rookie wiki" user find additional information?

Thanks.

Stijloor.
 

Pancho

wikineer
Super Moderator
#6
Re: Using a wiki to implement a QMS

Where can a "rookie wiki" user find additional information?

Thanks.

Stijloor.
The term "wiki" has several related meanings. One is the website where information can be read and edited. A second is the body of information and cross-links. A third is the software that runs it. To differentiate, I sometimes call the first a "wiki space", the second the "wiki content" and the last the "wiki engine".

A wiki engine or space are not, by themselves, compliant or not with ISO 9001 or any other standard. The wiki content, as the body of documentation, of your implementation may be. And your organization gets to write it.

Wiki engines are many. The most popular is MediaWiki. At Geometrica we used ProjectForum and found it very straightforward to install and use, which was a great advantage when we got started. (Neither I nor anyone at Geometrica is affiliated to ProjectForum in any way).

One of the first realizations that we came to was that hot-links are incredibly useful. Our wiki home page, very early on, became a list of links to pages of indices of documents organized by processes and functions (i.e. Sales, Engineering, Procurement, Manufacturing, Construction, etc.).

As we built the wiki content, we started to "include" on every document the index of docs of their corresponding or closest area (process or function). By "included" I mean that the page of indices is displayed on the document itself, but as a side bar. This way, anyone browsing, say, an engineering document has immediate access to all other engineering documents. We also "included" links to every area in a top navigation bar, so that anyone can jump from area to area very quickly.

To get started, I'd recommend that you download one of the many free wiki engines and play with it. Once you get it installed, you may, for example upload to the wiki the documents for one of your company's processes as initial content. Hotlink the heck out of this new content and let their users loose on them. If you have the authority, compell them initially to use the wiki for changes to the documents. With a little luck, one by one they will come around (this is probably the hardest part). After some 3 or 4 do, you will start to see some "wiki magic". And you are off.

Good luck!
 

Le Chiffre

Quite Involved in Discussions
#7
Re: Using a wiki to implement a QMS

That's good advice, there really is no better way to learn than to try it for yourself. Familiarity with other Wikis is helpful, even Wikipedia. I found the concept of articles and categories to be the most misunderstood. Some Wikis have few categories and hundreds of articles (like the *cough* Elsmar Cove Wiki *cough*), whereas others create content in categories that are otherwise empty of articles.

The meat of the Wiki should be made up of articles. Generally, information should be written in articles and not categories. These are organized by being included in categories. Create a category if you intend it to contain multiple instances of similar articles (e.g. "Test cases"). Each article should be included in at least one category, but don't get carried away. Include your new article in the most appropriate (or immediate) category and allow that category to make it a member of other broader categories.
 

Pancho

wikineer
Super Moderator
#8
Re: Using a wiki to implement a QMS

Some Wikis have few categories and hundreds of articles (like the *cough* Elsmar Cove Wiki *cough*), whereas others create content in categories that are otherwise empty of articles.

Generally, information should be written in articles and not categories. Each article should be included in at least one category, but don't get carried away. Include your new article in the most appropriate (or immediate) category and allow that category to make it a member of other broader categories.
Agree, Le Chiffre. We gave up on Categories and substituted them with "wiki gnoming" to write up navigation indices. Its a bit more work, but in our experience categories were always so jumbled that they were useless.

BTW, in your opinion, why is the Cove's wiki not used much?
 

Le Chiffre

Quite Involved in Discussions
#9
Re: Using a wiki to implement a QMS

BTW, in your opinion, why is the Cove's wiki not used much?
Primarily because these forums are so comprehensive and convenient. Assuming people come here in search of a solution to a problem, the forums offer a search utility to check for an existing similar question or they post a new one and generally get a fairly good response within 24hrs.

I think the wiki vs. forum debate has happened here before but I believe people are more inclined to post individual opinions, however incomplete rather than collaborate on a complete and definitive answer.
 

Scott Catron

True Artisan
Super Moderator
#10
Re: Using a wiki to implement a QMS

The wiki started as an alternative to the Definitions, Acronyms, Abbreviations and Interpretations forum. The initial content was from Bill Pflanz's General Quality Assurance Glossary and grew from there. There are only a handful of Covers that learned wiki mark-up, so after the initial coding of the the glossary (done my Marc and myself on a previous version of the wiki), not much more has been done.

It's probably easier to find a quick definition of a term on the wiki, but if one wants to read interpretations and discussion, that is better served by the forums.
 
Last edited:
Thread starter Similar threads Forum Replies Date
C Document Control using Wiki - Cannot Create all Documents as Wiki Pages Document Control Systems, Procedures, Forms and Templates 10
Pancho Using a wiki for Document Control The Reading Room 10
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
P Comparing Two Test Variables Using Attribute Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Using real time shelf life study as accelerated ISO 13485:2016 - Medical Device Quality Management Systems 1
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
S Process Monitoring using SPC software Quality Assurance and Compliance Software Tools and Solutions 6
R Using Scrapped NC items for training Medical Device and FDA Regulations and Standards News 15
M What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
J Using MD on a flight EU Medical Device Regulations 9
K Using Google Drive/Docs ISO 13485:2016 - Medical Device Quality Management Systems 16
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
T Poisson regression using Minitab Statistical Analysis Tools, Techniques and SPC 3
T Using NICE for guidance during CER CE Marking (Conformité Européene) / CB Scheme 0
T Using Review articles from Pubmed for CER CE Marking (Conformité Européene) / CB Scheme 8
Tagin Using a meme generator to poke fun at quality Funny Stuff - Jokes and Humour 2
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
V MSA - Using a R&R study for a Tape Measure Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Using a Non Certified vendor Supplier Quality Assurance and other Supplier Issues 8
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 21
R Select the 1 Supplier based on the Parts Durability from 6 Supplier Samples using Minitab Using Minitab Software 11
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P Using Zinc Plated Steel in a Cleanroom Other Medical Device Related Standards 3
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
rerusk1 MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5

Similar threads

Top Bottom